USFDA CDRH New Device Approvals: XPS System with STEEN Solution Perfusate...

The FDA has recently approved the XPS System with STEEN Solution Perfusate to be marketed.  The XVIVO Perfusion System (XPS) with STEEN Solution Perfusate preserves donated lungs that do not initially meet the standard criteria for lung transplantation but may be transplantable if there is more time to observe and evaluate the organ’s function. 

Product Name: XVIVO Perfusion System (XPS) with STEEN Solution Perfusate
HDE Applicant: XVIVO Perfusion, Inc.
Address:  3666 S Inca Street, Englewood, CO  80110
Approval Date: August 12, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf12/H120003a.pdf

What is it?  The XVIVO Perfusion System (XPS) with STEEN Solution Perfusate preserves donated lungs that do not initially meet the standard criteria for lung transplantation but may be transplantable if there is more time to observe and evaluate the organ’s function.

The XPS System consists of hardware, software, STEEN solution, tubing sets, and an organ chamber. The XPS System houses the organ for preservation and perfuses it with a preservation solution, during which time the lungs can be assessed by the transplant surgeon. The STEEN Solution temporarily maintains the isolated lungs after removal from the donor.

When is it used?  The XPS System with STEEN Solution Perfusate is used to flush and preserve initially unacceptable donor lungs after removal and prior to transplantation, if they are found suitable for transplantation after reassessment.

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